The FDA hit Chinese API manufacturer Jiangsu Yongan Pharmaceuticals with a Form 483 over serious deficiencies relating to poor sanitation, record keeping and training. Source: Drug Industry Daily
Massive amounts of clinical trial data are lengthening drug development timelines as technical challenges create costly bottlenecks, according to a new industry survey from the Tufts Center for the Study…
A charity that helps low-income patients buy prescription drugs sued the federal government, claiming federal overreach left it unable to communicate with donors. Source: Drug Industry Daily
Alex Azar, President Trump’s nominee for Secretary of Health and Human Services, emphasized his view that “drug prices are too high” to the Senate Finance Committee, even as Democrats continued…
Our Jan. 2 article on the Drug Enforcement Administration’s proposal on fentanyl products incorrectly reported that the proposed Schedule I listing for fentanyl drugs would block all prescriptions. The proposed…
The FDA hit Amneal Pharmaceuticals with a Form 483 over cleaning, sanitation and quality control issues after an October inspection of the drugmaker’s Paterson, New Jersey facility. Source: Drug Industry…
The FDA issued a warning letter to Prosana Distribuciones in Mexico City for serious GMP violations and for producing an adulterated drug product. Source: Drug Industry Daily
The Patient Engagement Collaborative is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Transformation Initiative (CTTI),…
The FDA turned down a request from Novo Nordisk to deny ANDAs referencing its liraglutide-containing drugs without comparative studies. Source: Drug Industry Daily
The U.S. Court of Appeals for the Federal Circuit found that a district court was overly broad in its interpretation of patents in a lawsuit by a Teva subsidiary accusing…